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Gelsinger case and impact in Belgium
(Authors: M. Sneyers and M. Goossens - Last revised:
February 28, 2006
)
During the month of December 1999, the Division of Biosafety and Biotechnology (SBB) learned via the literature and Internet consultation about the death of a patient (Jesse Gelsinger) following the injection of an adenoviral vector, during the course of a gene therapy clinical trial run at Pennsylvania University. The SBB managed to gather the information publically available at this moment. This information has been summarised in a report.
Belgian report on Gelsinger case: available as PDF file in
English, in Dutch
and in French.
This report has been submitted to the Belgian Biosafety Advisory Council and to its Scientific Committee "Recombinant viral vectors, virosomes, recombinant vaccines, gene therapy" which held a meeting on June 27th, 2000. Considering the Gelsinger case as an example, the aim of the meeting was to evaluate the Belgian regulation processes of gene therapy clinical trials as well as the relationships existing between the different bodies playing a role in their application.
Minutes of this meeting: available as PDF file in
Dutch and in French.
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